Hemostatic Xerogel Sponge (K192671) - FDA 510(k) Clearance

K192671 is an FDA 510(k) clearance for the Hemostatic Xerogel Sponge. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Solaplus Biotech Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on August 28, 2020 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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